Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC

Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.

Inclusion Criteria:

• 18 - 65 years of age (Male and Female).
• Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
• Patients who had unresectable HCC with single tumor diameter > 5 cm and ≤ 10cm; or numbers of multiple tumors >3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
• Serum AFP ≤ 10000 ng/ml before liver transplantation.
• Child-pugh A-B.
• No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs.
• Provide written informed consent before screening.

Exclusion Criteria:

• Metastasis in extrahepatic organs.
• HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
• Contraindications of operation of other organ system.
• Hypersensitivity to adenovirus, GCV or similar drugs.
• Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
• Plan to accept clinical trials of other antitumor drugs.
• Immunological deficit.
• HBsAg(+) and HBcAb(+) donor.
• Unsuitable participate assessed by investigator.